Reported May 14, 2014 · Terminated
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 8880 Gorman Rd · Laurel, MD · 20723-5800
Is this the product you have?
- Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
- Lot codes and dates
723 of 723 codes
HDJR50780HDJR50781HDJR56911HDJR57608HDJR57609HDJR57610HDJR57611HDJR57636HDJR57637HDJR57638HDJR57692HDJR57693HDJR57694HDJR57695HDJR57696HDJR57697HDJR57698HDJR57699HDJR57700HDJR57701HDJR57702HDJR57703HDJR57704HDJR57705HDJR57706HDJR57707HDJR57784HDJR57785HDJR57786HDJR57787HDJR57788HDJR57789HDJR57790HDJR57791HDJR57792HDJR57793HDJR57794HDJR57795HDJR57925HDJR57926HDJR57935HDJR57936HDJR57937HDJR57938HDJR57939HDJR57944HDJR57948HDJR57949HDJR57950HDJR57951HDJR57952HDJR57953HDJR57954HDJR57955HDJR57956HDJR57957HDJR57980HDJR57981HDJR57985HDJR57986
- Amount recalled
- 723 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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